CLINICAL PRACTICE GUIDELINE Management of Newly … · Type 1 diabetes mellitus (T1DM): Diabetes secondary to autoimmune destruction of β cells resulting in absolute (complete or

CLINICAL PRACTICE GUIDELINE

Management of Newly Diagnosed Type 2 DiabetesMellitus (T2DM) in Children and Adolescents

abstractOver the past 3 decades, the prevalence of childhood obesity has increaseddramatically in North America, ushering in a variety of health problems,including type 2 diabetes mellitus (T2DM), which previously was not typicallyseen until much later in life. The rapid emergence of childhood T2DM poseschallenges to many physicians who find themselves generally ill-equipped totreat adult diseases encountered in children. This clinical practice guidelinewas developed to provide evidence-based recommendations on managing10- to 18-year-old patients in whom T2DM has been diagnosed. The AmericanAcademy of Pediatrics (AAP) convened a Subcommittee on Management ofT2DM in Children and Adolescents with the support of the American DiabetesAssociation, the Pediatric Endocrine Society, the American Academy of FamilyPhysicians, and the Academy of Nutrition and Dietetics (formerly the Amer-ican Dietetic Association). These groups collaborated to develop an evidencereport that served as amajor source of information for these practice guide-line recommendations. The guideline emphasizes the use of managementmodalities that have been shown to affect clinical outcomes in this pediatricpopulation. Recommendations are made for situations in which either in-sulin or metformin is the preferred first-line treatment of children and ado-lescents with T2DM. The recommendations suggest integrating lifestylemodifications (ie, diet and exercise) in concert with medication rather thanas an isolated initial treatment approach. Guidelines for frequency of mon-itoring hemoglobin A1c (HbA1c) and finger-stick blood glucose (BG) concen-trations are presented. Decisions were made on the basis of a systematicgrading of the quality of evidence and strength of recommendation. Theclinical practice guideline underwent peer review before it was approvedby the AAP. This clinical practice guideline is not intended to replace clinicaljudgment or establish a protocol for the care of all children with T2DM, andits recommendations may not provide the only appropriate approach to themanagement of children with T2DM. Providers should consult expertstrained in the care of children and adolescents with T2DM when treatmentgoals are not met or when therapy with insulin is initiated. The AAP acknowl-edges that some primary care clinicians may not be confident of their abilityto successfully treat T2DM in a child because of the child’s age, coexistingconditions, and/or other concerns. At any point at which a clinician feels heor she is not adequately trained or is uncertain about treatment, a referralto a pediatric medical subspecialist should be made. If a diagnosis of T2DMis made by a pediatric medical subspecialist, the primary care clinicianshould develop a comanagement strategy with the subspecialist to ensurethat the child continues to receive appropriate care consistent with a med-ical home model in which the pediatrician partners with parents to ensurethat all health needs are met. Pediatrics 2013;131:364–382

Kenneth C. Copeland, MD, Janet Silverstein, MD, Kelly R.Moore, MD, Greg E. Prazar, MD, Terry Raymer, MD, CDE,Richard N. Shiffman, MD, Shelley C. Springer, MD, MBA,Vidhu V. Thaker, MD, Meaghan Anderson, MS, RD, LD, CDE,Stephen J. Spann, MD, MBA, and Susan K. Flinn, MA

KEY WORDSdiabetes, type 2 diabetes mellitus, childhood, youth, clinicalpractice guidelines, comanagement, management, treatment

ABBREVIATIONSAAP—American Academy of PediatricsAAFP—American Academy of Family PhysiciansBG—blood glucoseFDA—US Food and Drug AdministrationHbA1c—hemoglobin A1cPES—Pediatric Endocrine SocietyT1DM—type 1 diabetes mellitusT2DM—type 2 diabetes mellitusTODAY—Treatment Options for type 2 Diabetes in Adolescentsand Youth

This document is copyrighted and is property of the AmericanAcademy of Pediatrics and its Board of Directors. All authorshave filed conflict of interest statements with the AmericanAcademy of Pediatrics. Any conflicts have been resolved througha process approved by the Board of Directors. The AmericanAcademy of Pediatrics has neither solicited nor accepted anycommercial involvement in the development of the content ofthis publication.

The recommendations in this report do not indicate an exclusivecourse of treatment or serve as a standard of medical care.Variations, taking into account individual circumstances, may beappropriate.

All clinical practice guidelines from the American Academy ofPediatrics automatically expire 5 years after publication unlessreaffirmed, revised, or retired at or before that time.

www.pediatrics.org/cgi/doi/10.1542/peds.2012-3494

doi:10.1542/peds.2012-3494

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Organizational Principles to Guide and Define the ChildHealth Care System and/or Improve the Health of all Children

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Key action statements are as follows:

1. Clinicians must ensure that insulintherapy is initiated for childrenand adolescents with T2DM whoare ketotic or in diabetic ketoacidosisand in whom the distinction be-tween types 1 and 2 diabetes mel-litus is unclear and, in usual cases,should initiate insulin therapy forpatients

a. who have random venous orplasma BG concentrations ≥250mg/dL; or

b. whose HbA1c is >9%.

2. In all other instances, cliniciansshould initiate a lifestyle modifi-cation program, including nutri-tion and physical activity, andstart metformin as first-linetherapy for children and adoles-

cents at the time of diagnosis ofT2DM.

3. The committee suggests that clini-cians monitor HbA1c concentra-tions every 3 months and intensifytreatment if treatment goals forfinger-stick BG and HbA1c concen-trations are not being met (intensi-fication is defined in the Definitionsbox).

4. The committee suggests that clini-cians advise patients to monitorfinger-stick BG (see Key ActionStatement 4 in the guideline forfurther details) concentrations inpatients who

a. are taking insulin or other med-ications with a risk of hypoglyce-mia; or

b. are initiating or changing theirdiabetes treatment regimen; or

c. have not met treatment goals; ord. have intercurrent illnesses.

5. The committee suggests that clini-cians incorporate the Academyof Nutrition and Dietetics’ PediatricWeight Management Evidence-BasedNutrition Practice Guidelines in theirdietary or nutrition counseling ofpatients with T2DM at the time ofdiagnosis and as part of ongoingmanagement.

6. The committee suggests that clini-cians encourage children and ado-lescents with T2DM to engage inmoderate-to-vigorous exercise forat least 60 minutes daily and tolimit nonacademic “screen time”to less than 2 hours a day.

Definitions

Adolescent: an individual in various stages of maturity, generally considered to be between 12 and 18 years of age.

Childhood T2DM: disease in the child who typically

� is overweight or obese (BMI ≥85th–94th and >95th percentile for age and gender, respectively);

� has a strong family history of T2DM;

� has substantial residual insulin secretory capacity at diagnosis (reflected by normal or elevated insulin andC-peptide concentrations);

� has insidious onset of disease;

� demonstrates insulin resistance (including clinical evidence of polycystic ovarian syndrome or acanthosisnigricans);

� lacks evidence for diabetic autoimmunity (negative for autoantibodies typically associated with T1DM). These patientsare more likely to have hypertension and dyslipidemia than are those with T1DM.

Clinician: any provider within his or her scope of practice; includes medical practitioners (including physicians andphysician extenders), dietitians, psychologists, and nurses.Diabetes: according to the American Diabetes Association criteria, defined as

1. HbA1c ≥6.5% (test performed in an appropriately certified laboratory); or

2. fasting (defined as no caloric intake for at least 8 hours) plasma glucose ≥126 mg/dL (7.0 mmol/L); or

3. 2-hour plasma glucose ≥200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test performed as described bythe World Health Organization by using a glucose load containing the equivalent of 75 g anhydrous glucose dissolvedin water; or

4. a random plasma glucose ≥200 mg/dL (11.1 mmol/L) with symptoms of hyperglycemia.

PEDIATRICS Volume 131, Number 2, February 2013 365

FROM THE AMERICAN ACADEMY OF PEDIATRICS


INTRODUCTION

Over the past 3 decades, the preva-lence of childhood obesity has in-creased dramatically in NorthAmerica,1–5 ushering in a variety ofhealth problems, including type 2 di-abetes mellitus (T2DM), which pre-viously was not typically seen untilmuch later in life. Currently, in theUnited States, up to 1 in 3 new casesof diabetes mellitus diagnosed inyouth younger than 18 years is T2DM

(depending on the ethnic compositionof the patient population),6,7 witha disproportionate representationin ethnic minorities8,9 and occurringmost commonly among youth be-tween 10 and 19 years of age.5,10

This trend is not limited to theUnited States but is occurring in-ternationally11; it is projected thatby the year 2030, an estimated 366million people worldwide will havediabetes mellitus.12

The rapid emergence of childhoodT2DM poses challenges to manyphysicians who find themselves gen-erally ill-equipped to treat adult dis-eases encountered in children. Mostdiabetes education materials designedfor pediatric patients are directedprimarily to families of children withtype 1 diabetes mellitus (T1DM) andemphasize insulin treatment and glu-cose monitoring, which may or maynot be appropriate for children with

(In the absence of unequivocal hyperglycemia, criteria 1–3 should be confirmed by repeat testing.)

Diabetic ketoacidosis: acidosis resulting from an absolute or relative insulin deficiency, causing fat breakdown andformation of β hydroxybutyrate. Symptoms include nausea, vomiting, dehydration, Kussmaul respirations, and alteredmental status.

Fasting blood glucose: blood glucose obtained before the first meal of the day and after a fast of at least 8 hours.

Glucose toxicity: The effect of high blood glucose causing both insulin resistance and impaired β-cell production of insulin.

Intensification: Increase frequency of blood glucose monitoring and adjustment of the dose and type of medication in anattempt to normalize blood glucose concentrations.

Intercurrent illnesses: Febrile illnesses or associated symptoms severe enough to cause the patient to stay home fromschool and/or seek medical care.

Microalbuminuria: Albumin:creatinine ratio ≥30 mg/g creatinine but <300 mg/g creatinine.

Moderate hyperglycemia: blood glucose = 180–250 mg/dL.

Moderate-to-vigorous exercise : exercise that makes the individual breathe hard and perspire and that raises his or herheart rate. An easy way to define exercise intensity for patients is the “talk test”: during moderate physical activitya person can talk, but not sing. During vigorous activity, a person cannot talk without pausing to catch a breath.

Obese: BMI ≥95th percentile for age and gender.

Overweight: BMI between the 85th and 94th percentile for age and gender.

Prediabetes: Fasting plasma glucose ≥100–125 mg/dL or 2-hour glucose concentration during an oral glucose tolerancetest ≥126 but <200 mg/dL or an HbA1c of 5.7% to 6.4%.

Severe hyperglycemia: blood glucose >250 mg/dL.

Thiazolidinediones (TZDs): Oral hypoglycemic agents that exert their effect at least in part by activation of the peroxisomeproliferator-activated receptor γ.

Type 1 diabetes mellitus (T1DM): Diabetes secondary to autoimmune destruction of β cells resulting in absolute (completeor near complete) insulin deficiency and requiring insulin injections for management.

Type 2 diabetes mellitus (T2DM): The investigators’ designation of the diagnosis was used for the purposes of the lit-erature review. The committee acknowledges the distinction between T1DM and T2DM in this population is not alwaysclear cut, and clinical judgment plays an important role. Typically, this diagnosis is made when hyperglycemia is sec-ondary to insulin resistance accompanied by impaired β-cell function resulting in inadequate insulin production tocompensate for the degree of insulin resistance.

Youth: used interchangeably with “adolescent” in this document.

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T2DM.13,14 The National Diabetes Edu-cation Program TIP sheets (which canbe ordered or downloaded from www.yourdiabetesinfo.org or ndep.nih.gov)provide guidance on healthy eating,physical activity, and dealing withT2DM in children and adolescents, butfew other resources are available thatare directly targeted at youth with thisdisease.15 Most medications used forT2DM have been tested for safety andefficacy only in people older than 18years, and there is scant scientificevidence for optimal management ofchildren with T2DM.16,17 Recognizing thescarcity of evidence-based data, thisreport provides a set of guidelines forthe management and treatment ofchildren with T2DM that is based ona review of current medical literaturecovering a period from January 1, 1990,to July 1, 2008.

Despite these limitations, the practic-ing physician is likely to be faced withthe need to provide care for childrenwith T2DM. Thus, the American Acad-emy of Pediatrics (AAP), the PediatricEndocrine Society (PES), the AmericanAcademy of Family Physicians (AAFP),American Diabetes Association, andthe Academy of Nutrition and Dietetics(formerly the American Dietetic Asso-ciation) partnered to develop a set ofguidelines that might benefit endo-crinologists and generalists, includingpediatricians and family physiciansalike. This clinical practice guidelinemay not provide the only appropriateapproach to the management of chil-dren with T2DM. It is not expected toserve as a sole source of guidance inthe management of children and ado-lescents with T2DM, nor is it intended toreplace clinical judgment or establisha protocol for the care of all childrenwith this condition. Rather, it is intendedto assist clinicians in decision-making.

Primary care providers should en-deavor to obtain the requisite skills tocare for children and adolescents with

T2DM, and should communicate andwork closely with a diabetes team ofsubspecialists when such consultationis available, practical, and appropriate.The frequency of such consultationswill vary, but should usually beobtained at diagnosis and then at leastannually if possible. When treatmentgoals are not met, the committeeencourages clinicians to consult withan expert trained in the care of chil-dren and adolescents with T2DM.18,19

When first-line therapy (eg, metfor-min) fails, recommendations for in-tensifying therapy should be generallythe same for pediatric and adultpopulations. The picture is constantlychanging, however, as new drugs areintroduced, and some drugs that ini-tially appeared to be safe demon-strate adverse effects with wider use.Clinicians should, therefore, remainalert to new developments with regardto treatment of T2DM. Seeking the ad-vice of an expert can help ensure thatthe treatment goals are appropriatelyset and that clinicians benefit fromcutting-edge treatment information inthis rapidly changing area.

The Importance of Family-CenteredDiabetes Care

Family structure, support, and educa-tion help inform clinical decision-makingand negotiations with the patient andfamily about medical preferences thataffect medical decisions, independentof existing clinical recommendations.Because adherence is a major issue inany lifestyle intervention, engaging thefamily is critical not only to maintainneeded changes in lifestyle but also tofoster medication adherence.20–22 Thefamily’s ideal role in lifestyle inter-ventions varies, however, depend-ing on the child’s age. Behavioralinterventions in younger childrenhave shown a favorable effect. Withadolescents, however, interventionsbased on target-age behaviors (eg,including phone or Internet-based

interventions as well as face-to-face or peer-enhanced activities)appear to foster better results, atleast for weight management.23

Success in making lifestyle changesto attain therapeutic goals requiresthe initial and ongoing education of thepatient and the entire family abouthealthy nutrition and exercise. Any be-havior change recommendations mustestablish realistic goals and take intoaccount the families’ health beliefsand behaviors. Understanding the pa-tient and family’s perception of thedisease (and overweight status) beforeestablishing a management plan is im-portant to dispel misconceptions andpromote adherence.24 Because T2DMdisproportionately affects minority pop-ulations, there is a need to ensure cul-turally appropriate, family-centered carealong with ongoing education.25–28 Sev-eral observational studies cite the im-portance of addressing cultural issueswithin the family.20–22

Restrictions in Creating ThisDocument

In developing these guidelines, thefollowing restrictions governed thecommittee’s work:

� Although the importance of diabe-tes detection and screening of at-risk populations is acknowledgedand referenced, the guidelinesare restricted to patients meetingthe diagnostic criteria for diabetes(eg, this document focuses ontreatment postdiagnosis). Specifi-cally, this document and its recom-mendations do not pertain topatients with impaired fastingplasma glucose (100–125 mg/dL)or impaired glucose tolerance (2-hour oral glucose tolerance testplasma glucose: 140–200 mg/dL)or isolated insulin resistance.

� Although it is noted that the dis-tinction between types 1 and 2 di-abetes mellitus in children may be




www.yourdiabetesinfo.org


difficult,29,30 these recommendationspertain specifically to patients 10to less than 18 years of age withT2DM (as defined above).

� Although the importance of high-riskcare and glycemic control in preg-nancy, including pregravid glycemia,is affirmed, the evidence consideredand recommendations contained inthis document do not pertain to di-abetes in pregnancy, including dia-betes in pregnant adolescents.

� Recommended screening sched-ules and management tools forselect comorbid conditions (hyper-tension, dyslipidemia, nephropathy,microalbuminuria, and depression)are provided as resources in theaccompanying technical report.31

These therapeutic recommenda-tions were adapted from other rec-ommended guideline documentswith references, without an inde-pendent assessment of their sup-porting evidence.

METHODS

A systematic review was performedand is described in detail in the ac-companying technical report.31 To de-velop the clinical practice guideline onthe management of T2DM in childrenand adolescents, the AAP convenedthe Subcommittee on Management ofT2DM in Children and Adolescentswith the support of the American Di-abetes Association, the PES, the AAFP,and the Academy of Nutrition andDietetics. The subcommittee wasco-chaired by 2 pediatric endocrinol-ogists preeminent in their field andincluded experts in general pediat-rics, family medicine, nutrition, NativeAmerican health, epidemiology, andmedical informatics/guideline method-ology. All panel members reviewed theAAP policy on Conflict of Interest andVoluntary Disclosure and declared allpotential conflicts (see conflicts state-ments in the Task Force member list).

These groups partnered to developan evidence report that served as amajor source of information for thesepractice guideline recommendations.31

Specific clinical questions addressedin the evidence review were as fol-lows: (1) the effectiveness of treat-ment modalities for T2DM in childrenand adolescents, (2) the efficacy ofpharmaceutical therapies for treat-ment of children and adolescents withT2DM, (3) appropriate recommen-dations for screening for comorbid-ities typically associated with T2DMin children and adolescents, and (4)treatment recommendations for comor-bidities of T2DM in children and ado-lescents. The accompanying technicalreport contains more information oncomorbidities.31

Epidemiologic project staff searchedMedline, the Cochrane Collaboration,and Embase. MESH terms used invarious combinations in the searchincluded diabetes, mellitus, type 2, type1, treatment, prevention, diet, pediat-ric, T2DM, T1DM, NIDDM, metformin,lifestyle, RCT, meta-analysis, child, ad-olescent, therapeutics, control, adult,obese, gestational, polycystic ovarysyndrome, metabolic syndrome, car-diovascular, dyslipidemia, men, andwomen. In addition, the Boolean

operators NOT, AND, OR were included invarious combinations. Articles address-ing treatment of diabetes mellitus wereprospectively limited to those that werepublished in English between January1990 and June 2008, included abstracts,and addressed children between theages of 120 and 215 months with anestablished diagnosis of T2DM. Studiesin adults were considered for inclusionif >10% of the study population was45 years of age or younger. The Med-line search limits included the fol-lowing: clinical trial; meta-analysis;randomized controlled trial; review;child: 6–12 years; and adolescent:13–18 years. Additional articles wereidentified by review of reference listsof relevant articles and ongoingstudies recommended by a technicalexpert advisory group. All articleswere reviewed for compliance withthe search limitations and appro-priateness for inclusion in thisdocument.

Initially, 199 abstracts were identifiedfor possible inclusion, of which 52were retained for systematic review.Results of the literature review werepresented in evidence tables andpublished in the final evidence report.An additional literature search ofMedline and the Cochrane Database of

FIGURE 1Evidence quality. Integrating evidence quality appraisal with an assessment of the anticipated balancebetween benefits and harms if a policy is carried out leads to designation of a policy as a strongrecommendation, recommendation, option, or no recommendation.32 RCT, randomized controlledtrial; Rec, recommendation.


Systematic Reviews was performedin July 2009 for articles discussingrecommendations for screening andtreatment of 5 recognized comorbiditiesof T2DM: cardiovascular disease, dysli-pidemia, retinopathy, nephropathy, andperipheral vascular disease. Searchcriteria were the same as for the searchon treatment of T2DM, with the inclusionof the term “type 1 diabetes mellitus.”Search terms included, in various com-binations, the following: diabetes, melli-tus, type 2, type 1, pediatric, T2DM,T1DM, NIDDM, hyperlipidemia, retinopa-thy, microalbuminuria, comorbidities,screening, RCT, meta-analysis, child, andadolescent. Boolean operators andsearch limits mirrored those of theprimary search.

An additional 336 abstracts wereidentified for possible inclusion, ofwhich 26 were retained for systematicreview. Results of this subsequentliterature review were also presentedin evidence tables and published in

the final evidence report. An epide-miologist appraised the methodo-logic quality of the research before itwas considered by the committeemembers.

The evidence-based approach toguideline development requires thatthe evidence in support of each keyaction statement be identified, ap-praised, and summarized and that anexplicit link between evidence andrecommendations be defined. Evidence-based recommendations reflect thequality of evidence and the balance ofbenefit and harm that is anticipatedwhen the recommendation is followed.The AAP policy statement, “ClassifyingRecommendations for Clinical PracticeGuidelines,”32 was followed in desig-nating levels of recommendation (seeFig 1 and Table 1).

To ensure that these recommendationscan be effectively implemented, theGuidelines Review Group at Yale CenterforMedical Informatics provided feedback

on a late draft of these recommendations,using the GuideLine ImplementabilityAppraisal.33 Several potential obsta-cles to successful implementationwere identified and resolved in thefinal guideline. Evidence was in-corporated systematically into 6 keyaction statements about appropriatemanagement facilitated by BRIDGE-Wizsoftware (Building Recommendationsin a Developer’s Guideline Editor; YaleCenter for Medical Informatics).

A draft version of this clinical practiceguideline underwent extensive peer re-view by 8 groups within the AAP, theAmerican Diabetes Association, PES,AAFP, and the Academy of Nutrition andDietetics. Members of the subcommitteewere invited to distribute the draft toother representatives and committeeswithin their specialty organizations. Theresulting comments were reviewed bythe subcommittee and incorporated intothe guideline, as appropriate. All AAPguidelines are reviewed every 5 years.

TABLE 1 Definitions and Recommendation Implications

Statement Definition Implication

Strong recommendation A strong recommendation in favor of a particular action ismade when the anticipated benefits of the recommendedintervention clearly exceed the harms (as a strongrecommendation against an action is made when theanticipated harms clearly exceed the benefits) and thequality of the supporting evidence is excellent. In someclearly identified circumstances, strong recommendationsmay be made when high-quality evidence is impossible toobtain and the anticipated benefits strongly outweigh theharms.

Clinicians should follow a strong recommendation unlessa clear and compelling rationale for an alternative approachis present.

Recommendation A recommendation in favor of a particular action is made whenthe anticipated benefits exceed the harms but the quality ofevidence is not as strong. Again, in some clearly identifiedcircumstances, recommendations may be made when high-quality evidence is impossible to obtain but the anticipatedbenefits outweigh the harms.

Clinicians would be prudent to follow a recommendation butshould remain alert to new information and sensitive topatient preferences.

Option Options define courses that may be taken when either thequality of evidence is suspect or carefully performed studieshave shown little clear advantage to 1 approach overanother.

Clinicians should consider the option in their decision-making,and patient preference may have a substantial role.

No recommendation No recommendation indicates that there is a lack of pertinentpublished evidence and that the anticipated balance ofbenefits and harms is presently unclear.

Clinicians should be alert to new published evidence thatclarifies the balance of benefit versus harm.

It should be noted that, because childhood T2DM is a relatively recent medical phenomenon, there is a paucity of evidence for many or most of the recommendations provided. In somecases, supporting references for a specific recommendation are provided that do not deal specifically with childhood T2DM, such as T1DM, childhood obesity, or childhood “prediabetes,”or that were not included in the original comprehensive search. Committee members have made every effort to identify those references that did not affect or alter the level of evidencefor specific recommendations.




KEY ACTION STATEMENTS

Key Action Statement 1

Clinicians must ensure that insulintherapy is initiated for childrenand adolescents with T2DM whoare ketotic or in diabetic ketoaci-dosis and in whom the distinctionbetween T1DM and T2DM is unclear;and, in usual cases, should initiateinsulin therapy for patients:

a. who have random venous orplasma BG concentrations≥250 mg/dL; or

b. whose HbA1c is >9%.

(Strong Recommendation: evidencequality X, validating studies cannotbe performed, and C, observationalstudies and expert opinion; pre-ponderance of benefit over harm.)

The presentation of T2DM in childrenand adolescents varies according tothe disease stage. Early in the disease,before diabetes diagnostic criteria aremet, insulin resistance predominateswith compensatory high insulin se-cretion, resulting in normoglycemia.Over time, β cells lose their ability tosecrete adequate amounts of insulinto overcome insulin resistance, andhyperglycemia results. Early in this

process, blood glucose (BG) concen-trations may be normal much of thetime and the patient likely will beasymptomatic. At this stage, the dis-ease may only be detected by abnor-mal BG concentrations identifiedduring screening. As insulin secretiondeclines further, the patient is likely todevelop symptoms of hyperglycemia,occasionally with ketosis or frankketoacidosis. High glucose concen-trations can cause a reversible toxic-ity to islet β cells that contributesfurther to insulin deficiency. Of ado-lescents in whom T2DM is subse-quently diagnosed, 5% to 25% presentwith ketoacidosis.34

Diabetic ketoacidosis must be treatedwith insulin and fluid and electrolytereplacement to prevent worsening

metabolic acidosis, coma, and death.Children and adolescents with symp-toms of hyperglycemia (polyuria,polydipsia, and polyphagia) who arediagnosed with diabetes mellitusshould be evaluated for ketosis (serumor urine ketones) and, if positive, forketoacidosis (venous pH), even if theirphenotype and risk factor status(obesity, acanthosis nigricans, positivefamily history of T2DM) suggests

T2DM. Patients in whom ketoacidosisis diagnosed require immediatetreatment with insulin and fluid re-placement in an inpatient settingunder the supervision of a physicianwho is experienced in treating thiscomplication.

Youth and adolescents who present withT2DM with poor glycemic control (BGconcentrations ≥250 mg/dL or HbA1c>9%) but who lack evidence of ketosisor ketoacidosis may also benefit frominitial treatment with insulin, at least ona short-term basis.34 This allows forquicker restoration of glycemic con-trol and, theoretically, may allow isletβ cells to “rest and recover.”35,36

Furthermore, it has been noted thatinitiation of insulin may increaselong-term adherence to treatmentin children and adolescents withT2DM by enhancing the patient’s per-ception of the seriousness of the dis-ease.7,37–40 Many patients with T2DMcan be weaned gradually from insulintherapy and subsequently managedwith metformin and lifestyle modifica-tion.34

As noted previously, in some childrenand adolescents with newly diagnoseddiabetes mellitus, it may be difficult todistinguish between type 1 and type 2disease (eg, an obese child presentingwith ketosis).39,41 These patients arebest managed initially with insulintherapy while appropriate tests areperformed to differentiate betweenT1DM and T2DM. The care of chil-dren and adolescents who haveeither newly diagnosed T2DM orundifferentiated-type diabetes andwho require initial insulin treatmentshould be supervised by a physicianexperienced in treating diabeticpatients with insulin.


In all other instances, cliniciansshould initiate a lifestyle modifica-tion program, including nutrition

Action Statement Profile KAS 1Aggregate evidence quality X (validating studies cannot be performed)Benefits Avoidance of progression of diabetic ketoacidosis (DKA) and

worsening metabolic acidosis; resolution of acidosis andhyperglycemia; avoidance of coma and/or death. Quickerrestoration of glycemic control, potentially allowing islet βcells to “rest and recover,” increasing long-term adherenceto treatment; avoiding progression to DKA if T1DM. Avoidinghospitalization. Avoidance of potential risks associated withthe use of other agents (eg, abdominal discomfort, bloating,loose stools with metformin; possible cardiovascular riskswith sulfonylureas).

Harms/risks/cost Potential for hypoglycemia, insulin-induced weight gain, cost,patient discomfort from injection, necessity for BG testing,more time required by the health care team for patienttraining.

Benefits-harms assessment Preponderance of benefit over harm.Value judgments Extensive clinical experience of the expert panel was relied on in

making this recommendation.Role of patient preferences Minimal.Exclusions None.Intentional vagueness None.Strength Strong recommendation.


and physical activity, and startmetformin as first-line therapy

for children and adolescents at

the time of diagnosis of T2DM.

(Strong recommendation: evidence

quality B; 1 RCT showing improved

outcomes with metformin versus

lifestyle; preponderance of bene-

fits over harms.)

Metformin as First-Line Therapy

Because of the low success rate withdiet and exercise alone in pediatricpatients diagnosed with T2DM, met-formin should be initiated along withthe promotion of lifestyle changes,unless insulin is needed to reverseglucose toxicity in the case of signifi-cant hyperglycemia or ketoacidosis(see Key Action Statement 1). Becausegastrointestinal adverse effects arecommon with metformin therapy, the

committee recommends starting thedrug at a low dose of 500 mg daily,increasing by 500 mg every 1 to 2weeks, up to an ideal and maximumdose of 2000 mg daily in divideddoses.41 It should be noted that themain gastrointestinal adverse effects(abdominal pain, bloating, loosestools) present at initiation of met-formin often are transient and often

disappear completely if medication iscontinued. Generally, doses higherthan 2000 mg daily do not provideadditional therapeutic benefit.34,42,43 Inaddition, the use of extended-releasemetformin, especially with eveningdosing, may be considered, althoughdata regarding the frequency of ad-verse effects with this preparation arescarce. Metformin is generally bettertolerated when taken with food. It isimportant to recognize the paucity of

credible RCTs in adolescents withT2DM. The evidence to recommendinitiating metformin at diagnosis alongwith lifestyle changes comes from 1RCT, several observational studies, andconsensus recommendations.

Lifestyle modifications (including nu-trition interventions and increasedphysical activity) have long been thecornerstone of therapy for T2DM. Yet,medical practitioners recognize thateffecting these changes is both chal-lenging and often accompanied byregression over time to behaviors notconducive to maintaining the targetrange of BG concentrations. In pedi-atric patients, lifestyle change is mostlikely to be successful when a multi-disciplinary approach is used and theentire family is involved. (Encourage-ment of healthy eating and physicalexercise are discussed in Key ActionStatements 5 and 6.) Unfortunately,efforts at lifestyle change often fail fora variety of reasons, including highrates of loss to follow-up; a high rate ofdepression in teenagers, which affectsadherence; and peer pressure toparticipate in activities that oftencenter on unhealthy eating.

Expert consensus is that fewer than10% of pediatric T2DM patients will at-tain their BG goals through lifestyleinterventions alone.6,35,44 It is possiblethat the poor long-term success ratesobserved from lifestyle interventionsstem from patients’ perception that theintervention is not important becausemedications are not being prescribed.One might speculate that prescribingmedications, particularly insulin ther-apy, may convey a greater degree ofconcern for the patient’s health and theseriousness of the diagnosis, relative tothat conveyed when medications arenot needed, and that improved treat-ment adherence and follow-up mayresult from the use of medication. In-deed, 2 prospective observationalstudies revealed that treatment with

Action Statement Profile KAS 2Aggregate evidence quality B (1 randomized controlled trial showing improved outcomes

with metformin versus lifestyle combined with expertopinion).

Benefit Lower HbA1c, target HbA1c sustained longer, less earlydeterioration of BG, less chance of weight gain, improvedinsulin sensitivity, improved lipid profile.

Harm (of using metformin) Gastrointestinal adverse effects or potential for lactic acidosisand vitamin B12 deficiency, cost of medications, cost toadminister, need for additional instruction about medication,self-monitoring blood glucose (SMBG), perceived difficulty ofinsulin use, possible metabolic deterioration if T1DM ismisdiagnosed and treated as T2DM, potential risk of lacticacidosis in the setting of ketosis or significant dehydration.It should be noted that there have been no cases reported ofvitamin B12 deficiency or lactic acidosis with the use ofmetformin in children.

Benefits-harms assessment Preponderance of benefit over harm.Value judgments Committee members valued faster achievement of BG control

over not medicating children.Role of patient preferences Moderate; precise implementation recommendations likely will

be dictated by patient preferences regarding healthynutrition, potential medication adverse reaction, exercise,and physical activity.

Exclusions Although the recommendation to start metformin applies to all,certain children and adolescents with T2DM will not be ableto tolerate metformin. In addition, certain older or moredebilitated patients with T2DM may be restricted in theamount of moderate-to-vigorous exercise they can performsafely. Nevertheless, this recommendation applies to the vastmajority of children and adolescents with T2DM.

Intentional vagueness None.Policy level Strong recommendation.




lifestyle modification alone is associ-ated with a higher rate of loss tofollow-up than that found in patientswho receive medication.45

Before initiating treatment with met-formin, a number of important con-siderations must be taken intoaccount. First, it is important to de-termine whether the child with a newdiagnosis has T1DM or T2DM, and it iscritical to err on the side of caution ifthere is any uncertainty. The 2009Clinical Practice Consensus Guidelineson Type 2 Diabetes in Children andAdolescents from the InternationalSociety for Pediatric and AdolescentDiabetes provides more informationon the classification of diabetes inchildren and adolescents with newdiagnoses.46 If the diagnosis is un-clear (as may be the case when anobese child with diabetes presentsalso with ketosis), the adolescentmust be treated with insulin until theT2DM diagnosis is confirmed.47 Al-though it is recognized that somechildren with newly diagnosed T2DMmay respond to metformin alone, thecommittee believes that the presenceof either ketosis or ketoacidosis dic-tates an absolute initial requirementfor insulin replacement. (This isaddressed in Key Action Statement 1.)

Although there is little debate thata child presenting with significanthyperglycemia and/or ketosis requiresinsulin, children presenting with moremodest levels of hyperglycemia (eg,random BG of 200–249 mg/dL) orasymptomatic T2DM present addi-tional therapeutic challenges to theclinician. In such cases, metforminalone, insulin alone, or metforminwith insulin all represent reasonableoptions. Additional agents are likely tobecome reasonable options for initialpharmacologic management in thenear future. Although metformin andinsulin are the only antidiabetic agentscurrently approved by the US Food and

Drug Administration (FDA) for use inchildren, both thiazolidinediones andincretins are occasionally used inadolescents younger than 18 years.48

Metformin is recommended as theinitial pharmacologic agent in ado-lescents presenting with mild hyper-glycemia and without ketonuria orsevere hyperglycemia. In addition toimproving hepatic insulin sensitivity,metformin has a number of practicaladvantages over insulin:

� Potential weight loss or weightneutrality.37,48

� Because of a lower risk of hypogly-cemia, less frequent finger-stickBG measurements are requiredwith metformin, compared with insu-lin therapy or sulfonylureas.37,42,49–51

� Improves insulin sensitivity andmay normalize menstrual cyclesin females with polycystic ovarysyndrome. (Because metforminmay also improve fertility inpatients with polycystic ovary syn-drome, contraception is indicatedfor sexually active patients who wishto avoid pregnancy.)

� Taking pills does not have the discom-fort associated with injections.

� Less instruction time is required tostart oral medication, making it iseasier for busy practitioners toprescribe.

� Adolescents do not always acceptinjections, so oral medicationmight enhance adherence.52

Potential advantages of insulin overmetformin for treatment at diabetesonset include the following:

� Metabolic control may be achievedmore rapidly with insulin com-pared with metformin therapy.37

� With appropriate education and tar-geting the regimen to the individual,adolescents are able to accept anduse insulin therapy with improvedmetabolic outcomes.53

� Insulin offers theoretical benefitsof improved metabolic controlwhile preserving β-cell function oreven reversing β-cell damage.34,35

� Initial use of insulin therapy mayconvey to the patient a sense ofseriousness of the disease.7,53

Throughout the writing of theseguidelines, the authors have beenfollowing the progress of the NationalInstitute of Diabetes and Digestive andKidney Diseases–supported Treat-ment Options for type 2 Diabetes inAdolescents and Youth (TODAY) trial,54

designed to compare standard (met-formin alone) therapy versus moreaggressive therapy as the initialtreatment of youth with recent-onsetT2DM. Since the completion of theseguidelines, results of the TODAY trialhave become available and revealthat metformin alone is inadequatein effecting sustained glycemic con-trol in the majority of youth with di-abetes. The study also revealed thatthe addition of rosiglitazone to met-formin is superior to metforminalone in preserving glycemic control.Direct application of these findingsto clinical practice is problematic,however, because rosiglitazone is notFDA-approved for use in children, andits use, even in adults, is now se-verely restricted by the FDA becauseof serious adverse effects reportedin adults. Thus, the results suggestthat therapy that is more aggressivethan metformin monotherapy may berequired in these adolescents toprevent loss of glycemic control, butthey do not provide specific guidancebecause it is not known whether theeffect of the additional agent wasspecific to rosiglitazone or would beseen with the addition of otheragents. Unfortunately, there are lim-ited data for the use of other cur-rently available oral or injectedhypoglycemic agents in this agerange, except for insulin. Therefore,


the writing group for these guide-lines continues to recommend met-formin as first-line therapy in thisage group but with close monitoringfor glycemic deterioration and theearly addition of insulin or anotherpharmacologic agent if needed.

Lifestyle Modification, IncludingNutrition and Physical Activity

Although lifestyle changes are con-sidered indispensable to reachingtreatment goals in diabetes, no sig-nificant data from RCTs provide in-formation on success rates with suchan approach alone.

A potential downside for initiatinglifestyle changes alone at T2DM onsetis potential loss of patients to follow-up and worse health outcomes. Thevalue of lifestyle modification in themanagement of adolescents withT2DM is likely forthcoming after a moredetailed analysis of the lifestyle in-tervention arm of the multicenter TODAYtrial becomes available.54 As noted pre-viously, although it was published after

this guideline was developed, the TODAYtrial indicated that results from themetformin-plus-lifestyle intervention werenot significantly different from eithermetformin alone or the metformin-

plus-rosiglitazone intervention in main-taining glycemic control over time.54

Summary

As noted previously, metformin is a safeand effective agent for use at the time ofdiagnosis in conjunction with lifestylechanges. Although observational studiesand expert opinion strongly supportlifestyle changes as a key component ofthe regimen in addition to metformin,randomized trials are needed to de-lineate whether using lifestyle optionsalone is a reasonable first step intreating any select subgroups of chil-dren with T2DM.


The committee suggests that clini-cians monitor HbA1c concentrationsevery 3 months and intensify treat-ment if treatment goals for BG andHbA1c concentrations are not beingmet. (Option: evidence quality D;expert opinion and studies in chil-dren with T1DM and in adults withT2DM; preponderance of benefitsover harms.)

HbA1c provides a measure of glyce-mic control in patients with diabetesmellitus and allows an estimation ofthe individual’s average BG over theprevious 8 to 12 weeks. No RCTs have

evaluated the relationship betweenglycemic control and the risk of de-veloping microvascular and/or mac-rovascular complications in childrenand adolescents with T2DM. A num-ber of studies of children withT1DM55–57 and adults with T2DM have,however, shown a significant relation-ship between glycemic control (asmeasured by HbA1c concentration) andthe risk of microvascular complications(eg, retinopathy, nephropathy, and neu-ropathy).58,59 The relationship betweenHbA1c concentration and risk of mi-crovascular complications appears tobe curvilinear; the lower the HbA1cconcentration, the lower the downstreamrisk of microvascular complications, withthe greatest risk reduction seen at thehighest HbA1c concentrations.57

It is generally recommended thatHbA1c concentrations be measuredevery 3 months.60 For adults withT1DM, the American Diabetes Associ-ation recommends target HbA1c con-centrations of less than 7%; theAmerican Association of Clinical Endo-crinologists recommends target con-centrations of less than 6.5%. AlthoughHbA1c target concentrations for childrenand adolescents with T1DM are higher,13

several review articles suggest targetHbA1c concentrations of less than 7%for children and adolescents withT2DM.40,61–63 The committee concursthat, ideally, target HbA1c concentrationshould be less than 7% but notes thatspecific goals must be achievable for theindividual patient and that this concen-tration may not be applicable for allpatients. For patients in whom a targetconcentration of less than 7% seemsunattainable, individualized goals shouldbe set, with the ultimate goal of reachingguideline target concentrations. In addi-tion, in the absence of hypoglycemia,even lower HbA1c target concentrationscan be considered on the basis of anabsence of hypoglycemic events andother individual considerations.

Action Statement Profile KAS 3Aggregate evidence quality D (expert opinion and studies in children with T1DM and in adults with

T2DM; no studies have been performed in children and adolescentswith T2DM).

Benefit Diminishing the risk of progression of disease and deteriorationresulting in hospitalization; prevention of microvascularcomplications of T2DM.

Harm Potential for hypoglycemia from overintensifying treatment to reachHbA1c target goals; cost of frequent testing and medical consultation;possible patient discomfort.

Benefits-harms assessment Preponderance of benefits over harms.Value judgments Recommendation dictated by widely accepted standards of diabetic care.Role of patient

preferencesMinimal; recommendation dictated by widely accepted standards ofdiabetic care.

Exclusions None.Intentional vagueness Intentional vagueness in the recommendation as far as setting goals and

intensifying treatment attributable to limited evidence.Policy level Option.




When concentrations are found to beabove the target, therapy should beintensified whenever possible, with thegoal of bringing the concentration totarget. Intensification activities mayinclude, but are not limited to, in-creasing the frequency of clinic visits,engaging in more frequent BG moni-toring, adding 1 or more antidiabeticagents, meeting with a registered di-etitian and/or diabetes educator, andincreasing attention to diet and exer-cise regimens. Patients whose HbA1cconcentrations remain relatively sta-ble may only need to be tested every 6months. Ideally, real-time HbA1c con-centrations should be available at thetime of the patient’s visit with the clini-cian to allow the physician and patientand/or parent to discuss intensificationof therapy during the visit, if needed.


The committee suggests that clini-cians advise patients to monitorfinger-stick BG concentrations inthose who

a. are taking insulin or othermedications with a risk of hy-poglycemia; or

b. are initiating or changing theirdiabetes treatment regimen; or

c. have not met treatment goals; ord. have intercurrent illnesses.

(Option: evidence quality D; expertconsensus. Preponderance of ben-efits over harms.)

Glycemic control correlates closelywith the frequency of BG monitoring inadolescents with T1DM.64,65 Althoughstudies evaluating the efficacy of fre-quent BG monitoring have not beenconducted in children and adoles-cents with T2DM, benefits have beendescribed in insulin-treated adultswith T2DM who tested their BG 4 timesper day, compared with adults fol-lowing a less frequent monitoringregimen.66 These data support thevalue of BG monitoring in adultstreated with insulin, and likely arerelevant to youth with T2DM as well,especially those treated with insulin,at the onset of the disease, whentreatment goals are not met, andwhen the treatment regimen ischanged. The committee believes thatcurrent (2011) ADA recommendationsfor finger-stick BG monitoring apply tomost youth with T2DM67:

� Finger-stick BG monitoring shouldbe performed 3 or more times dailyfor patients using multiple insulininjections or insulin pump therapy.

� For patients using less-frequent in-sulin injections, noninsulin thera-pies, or medical nutrition therapyalone, finger-stick BG monitoringmay be useful as a guide to thesuccess of therapy.

� To achieve postprandial glucosetargets, postprandial finger-stickBG monitoring may be appropri-ate.

Recognizing that current practicesmay not always reflect optimal care,a 2004 survey of practices amongmembers of the PES revealed that36% of pediatric endocrinologistsasked their pediatric patients withT2DM to monitor BG concentrationstwice daily; 12% asked patients to doso once daily; 13% asked patients todo so 3 times per day; and 12% askedpatients to do so 4 times daily.61 Thequestionnaire provided to the pedi-atric endocrinologists did not askabout the frequency of BG monitor-ing in relationship to the diabetesregimen, however.

Although normoglycemia may bedifficult to achieve in adolescentswith T2DM, a fasting BG concentrationof 70 to 130 mg/dL is a reasonabletarget for most. In addition, becausepostprandial hyperglycemia has beenassociated with increased risk ofcardiovascular events in adults,postprandial BG testing may bevaluable in select patients. BG con-centrations obtained 2 hours aftermeals (and paired with pre-mealconcentrations) provide an index ofglycemic excursion, and may beuseful in improving glycemic control,particularly for the patient whosefasting plasma glucose is normal butwhose HbA1c is not at target.68 Rec-ognizing the limited evidence forbenefit of FSBG testing in this pop-ulation, the committee providessuggested guidance for testing fre-quency, tailored to the medicationregimen, as follows:

BG Testing Frequency for Patients WithNewly Diagnosed T2DM: Fasting,Premeal, and Bedtime Testing

The committee suggests that allpatients with newly diagnosed T2DM,regardless of prescribed treatmentplan, should perform finger-stick BGmonitoring before meals (includinga morning fasting concentration) and

Action Statement Profile KAS 4Aggregate evidence quality D (expert consensus).Benefit Potential for improved metabolic control, improved potential for

prevention of hypoglycemia, decreased long-term complications.Harm Patient discomfort, cost of materials.Benefits-harms assessment Benefit over harm.Value judgments Despite lack of evidence, there were general committee perceptions that

patient safety concerns related to insulin use or clinical statusoutweighed any risks from monitoring.

Role of patient preferences Moderate to low; recommendation driven primarily by safety concerns.Exclusions None.Intentional vagueness Intentional vagueness in the recommendation about specific

approaches attributable to lack of evidence and the need toindividualize treatment.

Policy level Option.


at bedtime until reasonable metaboliccontrol is achieved.69 Once BG con-centrations are at target levels, thefrequency of monitoring can be mod-ified depending on the medicationused, the regimen’s intensity, and thepatient’s metabolic control. Patientswho are prone to marked hypergly-cemia or hypoglycemia or who are ona therapeutic regimen associated withincreased risk of hypoglycemia willrequire continued frequent BG testing.Expectations for frequency and timingof BG monitoring should be clearly de-fined through shared goal-setting be-tween the patient and clinician. Theadolescent and family members shouldbe given a written action plan statingthe medication regimen, frequency andtiming of expected BG monitoring, aswell as follow-up instructions.

BG Testing Frequency for Patients onSingle Insulin Daily Injections and OralAgents

Single bedtime long-acting insulin:The simplest insulin regimen con-sists of a single injection of long-acting insulin at bedtime (basalinsulin only). The appropriateness ofthe insulin dose for patients usingthis regimen is best defined by thefasting/prebreakfast BG test. Forpatients on this insulin regimen, thecommittee suggests daily fasting BGmeasurements. This regimen is as-sociated with some risk of hypogly-cemia (especially overnight orfasting hypoglycemia) and may notprovide adequate insulin coveragefor mealtime ingestions throughoutthe day, as reflected by fasting BGconcentrations in target, but day-time readings above target. In suchcases, treatment with meglitinide(Prandin [Novo Nordisk Pharma-ceuticals] or Starlix [Novartis Phar-maceuticals]) or a short-actinginsulin before meals (see below)may be beneficial.

Oral agents: Once treatment goals aremet, the frequency of monitoring can bedecreased; however, the committeerecommends some continued BG test-ing for all youth with T2DM, at a fre-quency determined within the clinicalcontext (e.g. medication regimen, HbA1c,willingness of the patient, etc.). For ex-ample, an infrequent or intermittentmonitoring schedule may be adequatewhen the patient is using exclusively anoral agent associated with a low risk ofhypoglycemia and if HbA1c concen-trations are in the ideal or non-diabeticrange. A more frequent monitoringschedule should be advised duringtimes of illness or if symptoms of hy-perglycemia or hypoglycemia develop.

Oral agent plus a single injection ofa long-acting insulin: Some youth withT2DM can be managed successfully witha single injection of long-acting insulin inconjunction with an oral agent. Twice aday BG monitoring (fasting plus a sec-ond BG concentration – ideally 2-hourpost prandial) often is recommended, aslong as HbA1c and BG concentrationsremain at goal and the patient remainsasymptomatic.

BG Testing Frequency for PatientsReceiving Multiple Daily InsulinInjections (eg, Basal Bolus Regimens):Premeal and Bedtime Testing

Basal bolus regimens are commonlyused in children and youth with T1DMand may be appropriate for some youthwith T2DM as well. They are the mostlabor intensive, providing both basalinsulin plus bolus doses of short-actinginsulin at meals. Basal insulin is pro-vided through either the use of long-acting, relatively peak-free insulin (byneedle) or via an insulin pump. Bolusinsulin doses are given at meal-time,using one of the rapid-acting insulinanalogs. The bolus dose is calculated byusing a correction algorithm for thepremeal BG concentration as well asa “carb ratio,” in which 1 unit of

a rapid-acting insulin analog is givenfor “X” grams of carbohydrates inges-ted (see box below). When using thismethod, the patient must be willing andable to count the number of grams ofcarbohydrates in the meal and divideby the assigned “carb ratio (X)” toknow how many units of insulin shouldbe taken. In addition, the patient mustalways check BG concentrations beforethe meal to determine how much ad-ditional insulin should be given asa correction dose using an algorithmassigned by the care team if the fastingBG is not in target. Insulin pumps arebased on this concept of “basal-bolus”insulin administration and have thecapability of calculating a suggestedbolus dosage, based on inputted gramsof carbohydrates and BG concen-trations. Because the BG value deter-mines the amount of insulin to be givenat each meal, the recommended testingfrequency for patients on this regimenis before every meal.

Box 1 Example of Basal BolusInsulin RegimenIf an adolescent has a BG of 250mg/dL, is to consume a mealcontaining 60 g of carbohydrates,with a carbohydrate ratio of 1:10and an assigned correction doseof 1:25>125 (with 25 being theinsulin sensitivity and 125 mg/dLthe target blood glucose level),the mealtime bolus dose ofinsulin would be as follows:

60 g/10 “carb ratio” =

6 units rapid-acting insulin formeal

plus

(250–125)/25 = 125/25 =

5 units rapid-acting insulin forcorrection

Thus, total bolus insulin coverageat mealtime is: 11 U (6 + 5) ofrapid-acting insulin.





The committee suggests that clini-cians incorporate the Academy ofNutrition and Dietetics’ PediatricWeight Management Evidence-Based Nutrition Practice Guide-lines in the nutrition counseling of

patients with T2DM both at the timeof diagnosis and as part of ongoingmanagement. (Option; evidencequality D; expert opinion; pre-ponderance of benefits overharms. Role of patient preferenceis dominant.)

Consuming more calories than oneuses results in weight gain and isa major contributor to the increasingincidence of T2DM in children andadolescents. Current literature is in-conclusive about a single best mealplan for patients with diabetes mel-litus, however, and studies specifi-cally addressing the diet of childrenand adolescents with T2DM arelimited. Challenges to making rec-ommendations stem from the smallsample size of these studies, limit-ed specificity for children andadolescents, and difficulties in gen-eralizing the data from dietary re-search studies to the generalpopulation.

Although evidence is lacking in chil-dren with T2DM, numerous studieshave been conducted in overweight

children and adolescents, becausethe great majority of children withT2DM are obese or overweight atdiagnosis.26 The committee suggeststhat clinicians encourage childrenand adolescents with T2DM to followthe Academy of Nutrition and Di-etetics’ recommendations for main-taining healthy weight to promotehealth and reduce obesity in thispopulation. The committee recom-mends that clinicians refer patientsto a registered dietitian who hasexpertise in the nutritional needs ofyouth with T2DM. Clinicians shouldincorporate the Academy of Nutri-tion and Dietetics’ Pediatric WeightManagement Evidence-Based Nutri-tion Practice Guidelines, which de-scribe effective, evidence-basedtreatment options for weight man-

agement, summarized below (Acomplete list of these recom-mendations is accessible to healthcare professionals at: http://www.andevidencelibrary.com/topic.cfm?cat=4102&auth=1.)

According to the Academy of Nutri-tion and Dietetics’ guidelines, whenincorporated with lifestyle changes,balanced macronutrient diets at 900to 1200 kcal per day are associatedwith both short- and long-term (eg,≥ 1 year) improvements in weightstatus and body composition inchildren 6 to 12 years of age.70

These calorie recommendationsare to be incorporated with lifestylechanges, including increased activ-ity and possibly medication. Re-strictions of no less than 1200 kcalper day in adolescents 13 to 18years old result in improved weightstatus and body composition aswell.71 The Diabetes Prevention Pro-gram demonstrated that partic-ipants assigned to the intensivelifestyle-intervention arm had a re-duction in daily energy intake of 450kcal and a 58% reduction in pro-gression to diabetes at the 2.8-yearfollow-up.71 At the study’s end, 50%of the lifestyle-arm participants hadachieved the goal weight loss of atleast 7% after the 24-week curricu-lum and 38% showed weight loss ofat least 7% at the time of their mostrecent visit.72 The Academy of Nutri-tion and Dietetics recommends thatprotein-sparing, modified-fast (keto-genic) diets be restricted to childrenwho are >120% of their ideal bodyweight and who have a seriousmedical complication that wouldbenefit from rapid weight loss.71

Specific recommendations are forthe intervention to be short-term(typically 10 weeks) and to be con-ducted under the supervision ofa multidisciplinary team specializ-ing in pediatric obesity.

Action Statement Profile KAS 5Aggregate evidence quality D (expert opinion).Benefit Promotes weight loss; improves insulin sensitivity; contributes

to glycemic control; prevents worsening of disease; facilitatesa sense of well-being; and improves cardiovascular health.

Harm Costs of nutrition counseling; inadequate reimbursement ofclinicians’ time; lost opportunity costs vis-a-vis time andresources spent in other counseling activities.

Benefits-harms assessment Benefit over harm.Value judgments There is a broad societal agreement on the benefits of dietary

recommendations.Role of patient preference Dominant. Patients may have different preferences for how they

wish to receive assistance in managing their weight-lossgoals. Some patients may prefer a referral to a nutritionistwhile others might prefer accessing online sources of help.Patient preference should play a significant role indetermining an appropriate weight-loss strategy.

Exclusions None.Intentional vagueness Intentional vagueness in the recommendation about specific

approaches attributable to lack of evidence and the need toindividualize treatment.



http://www.andevidencelibrary.com/topic.cfm?cat=4102&tnqh_x0026;auth&tnqh_x003D;1



Regardless of the meal plan pre-scribed, some degree of nutritioneducation must be provided tomaximize adherence and positiveresults. This education should en-courage patients to follow healthyeating patterns, such as consuming 3meals with planned snacks per day,not eating while watching televisionor using computers, using smallerplates to make portions appearlarger, and leaving small amounts offood on the plate.73 Common dietaryrecommendations to reduce calorieintake and to promote weight loss inchildren include the following: (1)eating regular meals and snacks; (2)reducing portion sizes; (3) choosingcalorie-free beverages, except formilk; (4) limiting juice to 1 cup perday; (5) increasing consumption offruits and vegetables; (6) consuming3 or 4 servings of low-fat dairyproducts per day; (7) limiting intakeof high-fat foods; (8) limiting fre-quency and size of snacks; and (9)reducing calories consumed in fast-food meals.74


The committee suggests that clini-cians encourage children and ado-lescents with T2DM to engage inmoderate-to-vigorous exercise forat least 60 minutes daily and tolimit nonacademic screen time to

less than 2 hours per day. (Option:evidence quality D, expert opinionand evidence from studies of met-abolic syndrome and obesity; pre-ponderance of benefits over harms.Role of patient preference is domi-nant.)

Engaging in Physical Activity

Physical activity is an integral part ofweight management for preventionand treatment of T2DM. Although thereis a paucity of available data fromchildren and adolescents with T2DM,several well-controlled studies per-formed in obese children and ado-lescents at risk of metabolic syndromeand T2DM provide guidelines forphysical activity. (See the Resourcessection for tools on this subject.) Asummary of the references supportingthe evidence for this guideline can befound in the technical report.31

At present, moderate-to-vigorous ex-ercise of at least 60 minutes daily isrecommended for reduction of BMIand improved glycemic control inpatients with T2DM.75 “Moderate to

Recommendations From the Academy of Nutrition and Dietetics

Pediatric Weight Management Evidence-Based Nutrition Practice Guidelines

Recommendation Strength

Interventions to reduce pediatric obesity should bemulticomponent and include diet, physical activity,nutritional counseling, and parent or caregiverparticipation.

Strong

A nutrition prescription should be formulated as part of thedietary intervention in a multicomponent pediatric weightmanagement program.

Strong

Dietary factors that may be associated with an increased riskof overweight are increased total dietary fat intake andincreased intake of calorically sweetened beverages.

Strong

Dietary factors that may be associated with a decreased risk ofoverweight are increased fruit and vegetable intake.

Strong

A balanced macronutrient diet that contains no fewer than 900kcal per day is recommended to improve weight status inchildren aged 6–12 y who are medically monitored.

Strong

A balanced macronutrient diet that contains no fewer than1200 kcal per day is recommended to improve weight statusin adolescents aged 13–18 y who are medically monitored.

Strong

Family diet behaviors that are associated with an increasedrisk of pediatric obesity are parental restriction of highlypalatable foods, consumption of food away from home,increased meal portion size, and skipping breakfast.

Fair

Action Statement Profile KAS 6Aggregate evidence quality D (expert opinion and evidence from studies of metabolic

syndrome and obesity).Benefit Promotes weight loss; contributes to glycemic control; prevents

worsening of disease; facilitates the ability to performexercise; improves the person’s sense of well-being; andfosters cardiovascular health.

Harm Cost for patient of counseling, food, and time; costs for clinicianin taking away time that could be spent on other activities;inadequate reimbursement for clinician’s time.

Benefits-harms assessment Preponderance of benefit over harm.Value judgments Broad consensus.Role of patient preference Dominant. Patients may seek various forms of exercise. Patient

preference should play a significant role in creating anexercise plan.

Exclusions Although certain older or more debilitated patients with T2DMmay be restricted in the amount of moderate-to-vigorousexercise they can perform safely, this recommendationapplies to the vast majority of children and adolescents withT2DM.

Intentional vagueness Intentional vagueness on the sequence of follow-up contactattributable to the lack of evidence and the need toindividualize care.





vigorous exercise” is defined as exercisethat makes the individual breathe hardand perspire and that raises his or herheart rate. An easy way to define exer-cise intensity for patients is the “talktest”; during moderate physical activitya person can talk but not sing. Duringvigorous activity, a person cannot talkwithout pausing to catch a breath.76

Adherence may be improved if clini-cians provide the patient with a writ-ten prescription to engage in physicalactivity, including a “dose” describingideal duration, intensity, and fre-quency.75 When prescribing physicalexercise, clinicians are encouraged tobe sensitive to the needs of children,adolescents, and their families. Rou-tine, organized exercise may be be-yond the family’s logistical and/orfinancial means, and some familiesmay not be able to provide structuredexercise programs for their children.It is most helpful to recommend anindividualized approach that can beincorporated into the daily routine, istailored to the patients’ physical abil-ities and preferences, and recognizesthe families’ circumstances.77 For ex-ample, clinicians might recommendonly daily walking, which has beenshown to improve weight loss andinsulin sensitivity in adults withT2DM78 and may constitute “moderateto vigorous activity” for some childrenwith T2DM. It is also important torecognize that the recommended 60minutes of exercise do not have to beaccomplished in 1 session but can becompleted through several, shorterincrements (eg, 10–15 minutes).Patients should be encouraged toidentify a variety of forms of activitythat can be performed both easily andfrequently.77 In addition, providersshould be cognizant of the potentialneed to adjust the medication dosage,especially if the patient is receivinginsulin, when initiating an aggressivephysical activity program.

Reducing Screen Time

Screen time contributes to a sedentarylifestyle, especially when the child oradolescent eats while watching tele-vision or playing computer games. TheUS Department of Health and HumanServices recommends that individualslimit “screen time” spent watchingtelevision and/or using computersand handheld devices to less than 2hours per day unless the use is re-lated to work or homework.79 Physicalactivity may be gained either throughstructured games and sports orthrough everyday activities, such aswalking, ideally with involvement ofthe parents as good role models.

Increased screen time and food intakeand reduced physical activity are asso-ciated with obesity. There is good evi-dence that modifying these factors canhelp prevent T2DM by reducing theindividual’s rate of weight gain. The ev-idence profile in pediatric patients withT2DM is inadequate at this time, how-ever. Pending new data, the committeesuggests that clinicians follow the AAPCommittee on Nutrition’s guideline,Prevention of Pediatric Overweight andObesity. The guideline recommendsrestricting nonacademic screen time toa maximum of 2 hours per day anddiscouraging the presence of videoscreens and television sets in children’sbedrooms.80–82 The American MedicalAssociation’s Expert Panel on ChildhoodObesity has endorsed this guideline.

Valuable recommendations for en-hancing patient health include thefollowing:

� With patients and their families,jointly determining an individual-ized plan that includes specificgoals to reduce sedentary behav-iors and increase physical activity.

� Providing a written prescriptionfor engaging in 60-plus minutesof moderate-to-vigorous physicalactivities per day that includes

dose, timing, and duration. It is im-portant for clinicians to be sensi-tive to the needs of children,adolescents, and their families inencouraging daily physical exer-cise. Graded duration of exerciseis recommended for those youthwho cannot initially be active for60 minutes daily, and the exercisemay be accomplished through sev-eral, shorter increments (eg, 10–15 minutes).

� Incorporating physical activities in-to children’s and adolescents’ dailyroutines. Physical activity may begained either through structuredgames and sports or through ev-eryday activities, such as walking.

� Restricting nonacademic screentime to a maximum of 2 hoursper day.

� Discouraging the presence of videoscreens and television sets inchildren’s bedrooms.

Conversations pertaining to the KeyAction Statements should be clearlydocumented in the patient’s medicalrecord.

AREAS FOR FUTURE RESEARCH

As noted previously, evidence formedical interventions in children ingeneral is scant and is especiallylacking for interventions directed to-ward children who have developeddiseases not previously seen com-monly in youth, such as childhoodT2DM. Recent studies such as theSearch for Diabetes in Youth Study(SEARCH)—an observational multi-center study in 2096 youth with T2DMfunded by the Centers for DiseaseControl and Prevention and the Na-tional Institute of Diabetes and Di-gestive and Kidney Diseases—nowprovide a detailed description ofchildhood diabetes. Subsequent trialswill describe the short-term and en-during effects of specific interventions


on the progression of the disease withtime.

Although it is likely that children andadolescents with T2DM have an ag-gressive form of diabetes, as reflectedby the age of onset, future researchshould determine whether the associ-ated comorbidities and complications ofdiabetes also are more aggressive inpediatric populations than in adults andif they are more or less responsive totherapeutic interventions. Additionalresearch should explore whether earlyintroduction of insulin or the use ofparticular oral agents will preserveβ-cell function in these children, andwhether recent technologic advances(such as continuous glucose monitor-ing and insulin pumps) will benefitthis population. Additional issues thatrequire further study include thefollowing:

� To delineate whether using lifestyleoptions without medication is a re-liable first step in treating selectedchildren with T2DM.

� To determine whether BG monitor-ing should be recommended to allchildren and youth with T2DM, re-gardless of therapy used; what theoptimal frequency of BG monitor-ing is for pediatric patients onthe basis of treatment regimen;and which subgroups will be ableto successfully maintain glycemicgoals with less frequent monitor-ing.

� To explore the efficacy of school-and clinic-based diet and physicalactivity interventions to preventand manage pediatric T2DM.

� To explore the association betweenincreased “screen time” and re-duced physical activity with re-spect to T2DM’s risk factors.

RESOURCES

Several tools are available online toassist providers in improving patient

adherence to lifestyle modifications,including examples of activities to berecommended for patients:

� The American Academy of Pediat-rics:

� www.healthychildren.org

� www.letsmove.gov

� Technical Report: Managementof Type 2 Diabetes Mellitus inChildren and Adolescents.31

▪ Includes an overview andscreening tools for a varietyof comorbidities.

� Gahagan S, Silverstein J; Com-mittee on Native American ChildHealth and Section on Endocri-nology. Clinical report: preven-tion and treatment of type 2diabetes mellitus in children,with special emphasis on Amer-ican Indian and Alaska NativeChildren. Pediatrics. 2003;112(4):e328–e347. Available at:http://www.pediatrics.org/cgi/content/full/112/4/e32863

▪ Fig 3 presents a screeningtool for microalbumin.

� Bright Futures: http://brightfu-tures.aap.org/

� Daniels SR, Greer FR; Commit-tee on Nutrition. Lipid screeningand cardiovascular health inchildhood. Pediatrics. 2008;122(1):198–208. Available at:

� The American Diabetes Associa-tion: www.diabetes.org

� Management of dyslipidemiain children and adolescentswith diabetes. Diabetes Care.2003;26(7):2194–2197. Availableat: http://care.diabetesjournals.org/content/26/7/2194.full

� Academy of Nutrition and Dietetics:

� http://www.eatright.org/child-hoodobesity/

� http://www.eatright.org/kids/

� http://www.eatright.org/cps/rde/xchg/ada/hs.xsl/index.html

� Pediatric Weight ManagementEvidence-Based Nutrition Prac-tice Guidelines: http://www.adaevidencelibrary.com/topic.cfm?cat=2721

� American Heart Association:

� American Heart Association Circu-lation. 2006 Dec 12;114(24):2710-2738. Epub 2006 Nov 27. Review.

� Centers for Disease Control andPrevention:

� http://www.cdc.gov/obesity/childhood/solutions.html

� BMI and other growth chartscan be downloaded andprinted from the CDC Web site:http://www.cdc.gov/growth-charts.

� Center for Epidemiologic Stud-ies Depression Scale (CES-D):http://www.chcr.brown.edu/pcoc/cesdscale.pdf; see attach-ments

� Diagnostic and Statistical Manual ofMental Disorders. 4th ed. Washington,DC: American Psychiatric Associa-tion; 1994

� Let’s Move Campaign: www.lets-move.gov

� The Reach Institute. Guidelines forAdolescent Depression in PrimaryCare (GLAD-PC) Toolkit, 2007. Con-tains a listing of the criteria formajor depressive disorder as de-fined by the DSM-IV-TR. Availableat: http://www.gladpc.org

� The National Heart, Lung, andBlood Institute (NHLBI) hyperten-sion guidelines: http://www.nhlbi.nih.gov/guidelines/hypertension/child_tbl.htm

� The National Diabetes EducationProgram and TIP sheets (includingtip sheets on youth transitioning toadulthood and adult providers, Stay-ing Active, Eating Healthy, Ups andDowns of Diabetes, etc): www.ndep.nih.gov or www.yourdiabetesinfo.org




www.healthychildren.org

www.letsmove.gov

http://www.pediatrics.org/cgi/content/full/112/4/e328

http://www.pediatrics.org/cgi/content/full/112/4/e328

http://brightfutures.aap.org/

http://brightfutures.aap.org/

www.diabetes.org

http://care.diabetesjournals.org/content/26/7/2194.full

http://care.diabetesjournals.org/content/26/7/2194.full

http://www.eatright.org/childhoodobesity/

http://www.eatright.org/childhoodobesity/

http://www.eatright.org/kids/

http://www.eatright.org/cps/rde/xchg/ada/hs.xsl/index.html

http://www.eatright.org/cps/rde/xchg/ada/hs.xsl/index.html

http://www.adaevidencelibrary.com/topic.cfm?cat=2721



http://www.cdc.gov/obesity/childhood/solutions.html

http://www.cdc.gov/obesity/childhood/solutions.html

http://www.cdc.gov/growthcharts

http://www.cdc.gov/growthcharts

http://www.chcr.brown.edu/pcoc/cesdscale.pdf

http://www.chcr.brown.edu/pcoc/cesdscale.pdf

www.letsmove.gov

www.letsmove.gov

http://www.gladpc.org

http://www.nhlbi.nih.gov/guidelines/hypertension/child_tbl.htm



www.ndep.nih.gov

www.ndep.nih.gov


� National High Blood Pressure Edu-cation Program Working Group onHigh Blood Pressure in Childrenand Adolescents, The Fourth Re-port on the Diagnosis, Evaluation,and Treatment of High Blood Pres-sure in Children and Adolescents: Pe-diatrics. 2004;114:555–576. Availableat: http://pediatrics.aappublications.org/content/114/Supplement_2/555.long

� National Initiative for Children’sHealthcare Quality (NICHQ): childhoodobesity section: http://www.nichq.org/childhood_obesity/index.html

� The National Institute of ChildHealth and Human Development(NICHD): www.NICHD.org

� President’s Council on Physical Fit-ness and Sports: http://www.presi-dentschallenge.org/home_kids.aspx

� US Department of Agriculture’s “MyPyramid” Web site:

� http://www.choosemyplate.gov/

� http://fnic.nal.usda.gov/life-cycle-nutrition/child-nutrition-and-health

SUBCOMMITTEE ON TYPE 2 DIABETES(OVERSIGHT BY THE STEERINGCOMMITTEE ON QUALITYIMPROVEMENT AND MANAGEMENT,2008–2012)Kenneth Claud Copeland, MD, FAAP: Co-chair—Endocrinology and Pediatric Endocrine So-ciety Liaison (2009: Novo Nordisk, Genentech,Endo [National Advisory Groups]; 2010: NovoNordisk [National Advisory Group]); publishedresearch related to type 2 diabetesJanet Silverstein, MD, FAAP: Co-chair—En-docrinology and American Diabetes AssociationLiaison (small grants with Pfizer, Novo Nordisk,and Lilly; grant review committee for Genentech;was on an advisory committee for Sanofi Aven-tis, and Abbott Laboratories for a 1-time meet-ing); published research related to type 2diabetesKelly Roberta Moore, MD, FAAP: GeneralPediatrics, Indian Health, AAP Committee onNative American Child Health Liaison (boardmember of the Merck Company Foundation

Alliance to Reduce Disparities in Diabetes.Their national program office is the Universityof Michigan’s Center for Managing ChronicDisease.)Greg Edward Prazar, MD, FAAP: General Pe-diatrics (no conflicts)Terry Raymer, MD, CDE: Family Medicine, In-dian Health Service (no conflicts)Richard N. Shiffman, MD, FAAP: Partnershipfor Policy Implementation Informatician, Gen-eral Pediatrics (no conflicts)Shelley C. Springer, MD, MBA, FAAP: Epide-miologist (no conflicts)Meaghan Anderson, MS, RD, LD, CDE: Acad-emy of Nutrition and Dietetics Liaison (formerlya Certified Pump Trainer for Animas)Stephen J. Spann, MD, MBA, FAAFP: Ameri-can Academy of Family Physicians Liaison (noconflicts)Vidhu V. Thaker, MD, FAAP: QuIIN Liaison,General Pediatrics (no conflicts)

CONSULTANTSusan K. Flinn, MA: Medical Writer (no con-flicts)

STAFFCaryn Davidson, MA

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